Fresh From the Bench: Latest Federal Circuit Court Cases

CASE OF THE WEEK

Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd. et al., Appeal Nos. 16-2707, 16-2708 (Fed. Cir. 2018)‎

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts.  The case presented unusual procedural circumstances in a Hatch-Waxman case, as the asserted patent did not issue until after the subject ANDA was filed, and plaintiffs filed their complaint before the ANDA was amended to include a Paragraph IV Certification that the asserted patent was believed to be invalid or not infringed.

The asserted patent claimed a method for treating schizophrenia patients with iloperidone, wherein one of two claimed dosage ranges is determined through an assessment of the patient’s genotype, as certain patients are unable to metabolize the drug efficiently.

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Written by: Scott D. Eads and Nika F. Aldrich, Schwabe, Williamson & Wyatt

Contributor: Jason Wrubleski